Notice: Prescription Drug List (PDL): Hydrocortisone

June 25, 2014
Our file number: 14-107199-353

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for hydrocortisone on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of hydrocortisone against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations. The wording, which remains unchanged from what was proposed in the February 20, 2014 Notice of Consultation, is:

Drugs containing any of the following: Adrenocortical hormones or their salts or derivatives

Including (but not limited to): hydrocortisone, hydrocortisone acetate, hydrocortisone valerate, hydrocortisone sodium succinate and clobetasone

Qualifier: Except:
(a) hydrocortisone or hydrocortisone acetate, when sold as a single medicinal ingredient in a concentration that provides 1.0% or less hydrocortisone in preparations for topical use on the skin; or
(b) hydrocortisone or hydrocortisone acetate, when sold in combination with any other non-prescription medicinal ingredient that provides 1.0% or less hydrocortisone in preparations for topical use on the skin; or
(c) clobetasone butyrate when sold in a concentration of 0.05% in cream preparations for topical use on the skin.

Effective Date: six months from date of this Notice

Consultation summary:

The proposal to amend the PDL was communicated to provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations through a Notice of Consultation posted on Health Canada's website on February 20, 2014. The 75 day consultation period which ended May 6, 2014 has been completed.

Only one comment was received and it was favourable.

Therefore, based on the results of this consultation, the Minister of Health intends to revise the listing for hydrocortisone by increasing the concentration from 0.5% to 1% for human nonprescription use as a single medicinal ingredient or in mixtures with other non-prescription ingredients in preparations for topical use on the skin. This revision will be in effect six months from the date of this Notice through a Notice of Amendment posted on the Health Canada website. Drug Identification Number (DIN) holders will be notified of the changes in labelling required and the regulatory framework they will fall under.

Should you have any questions on this update to the Prescription Drug List, please contact:

Prescription Drug Status Committee
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator 3102C3
Ottawa, Ontario
K1A 0K9

Email: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca
Phone: 613-957-1058
Facsimile: 613-941-5035